Stem Cell Treatment Shows Benefit in Traumatic Brain Injury


Peter J. McAllister, MD, FAAN, presented promising data from the phase 2 STEMTRA trial at AAN 2022.

This content originally appeared on our sister site, NeurologyLive.

SanBio’s investigational allogeneic bone marrow-derived modified mesenchymal stem cell therapy, SB623, for the treatment of traumatic brain injury (TBI), has show promise in the phase 2 STEMTRA trial (NCT02416492).

Meeting its primary end point, the data show a trend toward the maintenance of functional and activities of daily living improvements at 1 year. STEMTRA assessed the efficacy and safety of SB623 compared with sham surgery in individuals with chronic motor deficits from TBI.

Investigator Peter J. McAllister, MD, FAAN, board-certified neurologist and medical director and chief medical officer, New England Center for Neurology and Headache, presented the findings at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington. The trial included 61 patients, of whom 46 were treated and 15 underwent sham surgery. Those who received the treatment experienced significant improvements in motor function measured by Fugl-Meyer Motor Scale scores (SB623: 8.3 points [SD, 1.4]; Sham: 2.3 points [SD, 2.5]; P = .04).

McAllister shared his insight into the data and spoke about the importance of these results in TBI, which is complex to manage and has, to date, not seen an approved or effective treatment to address the complications of the condition. Additionally, he shared his perspective on the reaction to the data, which he described as “palpable.”

1. McAllister PJ. Efficacy and Safety Outcomes in Patients with Chronic Traumatic Brain Injury: Final Analysis of the Phase 2 STEMTRA Trial. Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual.
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